Description
The Clinical Data Coder is primarily responsible for providing support to activities related to coding of Clinical data for ongoing clinical studies. The Clinical Data Coder will also participate in various clinical data management activities required to ensure that data captured are collected, managed and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures (SOPs) while respecting Innovaderm’s commitment to sponsor’s requirements and timelines.
More specifically, the Clinical Data Coder must:
- Perform accurate coding of medical terms and medications utilizing industry-wide standards (MedDRA, WHO Drug) as well as company standards;
- Coordinate the assignment of appropriate dictionaries for meeting study requirements;
- Develop and maintain coding guidelines;
- Review and provide input to the Coding section of the Data Management Plan;
- Perform the Dictionary up-versioning activities and Synonym List upgrade;
- Validate/test the coding set up and programming of coding reports; may also test databases, edit specifications or any related programming activities;
- Conduct data review.
- Write and resolve data clarifications.
- Understand and comply with core operating procedures and work instructions.
- Perform other duties as directed by the Lead Data Manager.
- Meet objectives as assigned.
- Develop and maintain good communications and working relationships with the DM team.
Requirements
- Bachelor’s degree or educational equivalence in pharmacy, life sciences or related field or medical, nursing qualification with 2 years relevant experience or equivalent combination of education, training and experience;
- Thorough knowledge of Medical Terminology;
- Thorough knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD etc.);
- Experience working with clinical trials or within the pharmaceutical environment is preferred;
- Demonstrate understanding and experience in query management process;
- Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines;
- Excellent written and verbal English communication skills;
- Ability to work in a global team environment;
- Excellent organizational and analytical skills and high attention to detail;
- Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
Our company
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
- Flexible work schedule
- Permanent full-time position
- Company benefits package
- Ongoing learning and development
About Indero
Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.
Indero only accepts applicants who can legally work in India.
